Study protocol for the development of reporting guidelines for intervention adaptation studies: Transparent Reporting of Adaptations, Context and Effects (TRACE) – a multimethod approach using literature review, Delphi, crowdsourcing, webinar and usa

Introduction The adaptation of evidence-based interventions is widely recognised as essential for improving their relevance, acceptability and effectiveness across diverse populations and settings. While guidance for reporting intervention adaptations exists, it remains fragmented across frameworks, resulting in inconsistent and incomplete documentation. Such inconsistency in reporting limits our understanding of how interventions evolve across contexts and how adaptations influence implementation and clinical outcomes. The current fragmentation of recommendations for reporting and the lack of in-depth reporting of adaptation in studies are two of our justifications for developing Transparent Reporting of Adaptations, Context and Effects (TRACE), a reporting guideline specific to adaptation studies. Methods and analysis The development of TRACE will follow standard guidance to develop reporting guidelines and will comprise three main phases. Phase 1 includes a review of the literature on adaptation studies with the goal to: (a) identify definitions of adaptation, (b) identify definitions of adaptation studies, (c) identify the various designs, analysis and reporting features of methodological studies and (d) find any previous reporting guidance. Phase 2 involves Delphi and crowdsourcing methods to gather expert feedback on the proposed items for the TRACE guideline. Finally, in phase 3, we will finalise the checklist items and publish the guideline in a peer-reviewed journal. The goals of phases 2 and 3 are to gather feedback and develop consensus on: (a) definition of adaptation, (b) definition of adaptation study, (c) whether TRACE should be a modular/extension or standalone guideline and (d) which items should be included in TRACE. For phase 1, we will present a study flow diagram and summarise data in tables with explanatory text. Findings will be tabulated and synthesised with verbatim quotations. If the resulting studies are too heterogeneous for systematic review, we will shift to developing a narrative analysis of the findings. For phases 2–3, findings from the consensus exercises will be summarised descriptively in tables. We will measure levels of agreement for successive rounds and rounds with emergence of new feedback on the TRACE items or recommendations and instability for each round. If an item does not reach 80% agreement, it will go forward in the next round of evaluation with participants’ comments and suggestions for different wording. There are four sources of qualitative data across the phases: open texts from the surveys, discussion notes and transcripts from the Delphi meetings and from the webinar. We will conduct rapid qualitative content analysis of the data and organise it in a matrix to triangulate results and determine if there is agreement about the items across data collection episodes, as well as any other important suggestions that inform the development of the TRACE guidelines. Ethics and dissemination The study will follow the principles of the Declaration of Helsinki. The study has been registered in EQUATOR and in PROSPERO. We have received an exemption letter for phase 1, the systematic review. The study has been approved by the Washington University in St. Louis’ Institutional Review Board (#202603062) for phase 2 (the Delphi study). Because the next parts of the study depend on the Delphi data, we have not submitted the IRB protocol for these. Informed consent has been obtained for the Delphi phase and will be obtained for the crowdsourcing and webinar phases. The dissemination of TRACE and its products will be done through journal publications, conferences, a website and social media.